Épisodes

  • [European Union] Key Regulatory News on Cyber, Crypto, Healthcare, and Consumer Safety

    [European Union] Key Regulatory News on Cyber, Crypto, Healthcare, and Consumer Safety
    Mar 2 2026
    This episode explores recent regulatory developments impacting key healthcare and consumer safety sectors including Ulcerative Colitis therapies, medical device safety notifications, risks from falsified medicines, and toy safety concerns.Among the major updates, Philips Respironics issued an urgent field safety notice on the BiPAP A40 Pro device discontinuation due to oxygen sensor alarm issues, requiring physician guidance for continued use or device replacement. Additionally, Erbe Elektromedizin GmbH recalled specific lots of flexible cryoprobes due to rupture risks potentially causing hearing loss.In pharmaceutical news, the European Medicines Agency summarized Entyvio (vedolizumab) authorisation details for Ulcerative Colitis management and introduced Ranluspec, a biosimilar to Lucentis for treating wet macular degeneration and other retinal disorders.Furthermore, the French DGCCRF issued a critical alert on asbestos contamination in sand-based toys, prompting recalls and commercialization suspension. The MHRA in the UK highlighted safety concerns over falsified Mounjaro KwikPen products and strengthened warnings on GLP-1 receptor agonists.For more information, visit the Carver Agents website.Articles mentioned:[MàJ] Vulnérabilité dans Cisco Catalyst SD-WANFCA selects 4 firms to test stablecoin innovation in its Regulatory SandboxESMA Publishes IFRS 18 Package: Public Statement and Q&As on the ESMA APM Guidelines23/02/2026 - Entyvio - vedolizumab24/02/2026 - Ranluspec - ranibizumabLondon construction boss gets suspended sentence, unpaid work order and six-year director banAlerte sur la présence d'amiante dans des jouets à base de sableCe qui change en mars 2026Multiples vulnérabilités dans les produits Mozilla (25 février 2026)24.02.2026 - Umsetzung des einstimmigen Beschlusses der Koordinierungsgruppe vom 13.11.2025 betreffend TranexamsäureUrgent Field Safety Notice for BiPAP A40 Pro, BiPAP A40 EFL, BiPAP A30 EFL by Respironics, Inc. PittsburghEL(26)A/09 - Class 2 Recall: KidNaps Melatonin Oral Solution - 23 Feb 2026Multiples vulnérabilités dans le noyau Linux de Red Hat (27 février 2026)Vulnérabilité dans Juniper Networks Junos OS Evolved (26 février 2026)Penning Financial Services ApS LicensedMHRA Safety Roundup: February 2026 - 25 Feb 2026Taxe sur les petits colis : comment ça marche ?Multiples vulnérabilités dans les produits Trend Micro (25 février 2026)Multiples vulnérabilités dans Cisco Catalyst SD-WAN (25 février 2026)Urgent Field Safety Notice for Flexible cryoprobe, single-use by Erbe Elektromedizin GmbH
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    Indisponible
  • [European Union] Key Regulatory Updates on Markets and EU Eastern Border

    [European Union] Key Regulatory Updates on Markets and EU Eastern Border
    Feb 23 2026
    This episode covers regulatory updates in Sanctions, Pump and Dump, Position Limits, Market Abuse, EU Eastern Border.The European Commission has launched a comprehensive strategy to support the EU's eastern border regions adjacent to Russia, Belarus, and Ukraine, focusing on security, economic growth, connectivity, and social support.In financial markets, ESMA has issued public notices regarding significant supervisory measures and fines imposed on REGIS-TR due to multiple regulatory infringements, emphasizing the need for stringent governance and risk management in trade repositories.MiCA, the Markets in Crypto-Assets regulation, marks its first year in effect, establishing a robust European framework for crypto-asset service providers, enhancing governance, compliance, and investor protection.The French ACPR has clarified authorization expectations for payment institutions offering services that overlap payment and crypto-asset categories under PSD2.Additional topics include regulatory measures addressing sanctions enforcement, pump and dump schemes, position limits on derivatives, and market abuse vigilance.For more information, visit the Carver Agents website.Articles mentioned:Entwurf eines Gesetzes zur Änderung des Preisangabenrechts zur Sanktionierung von Verstößen gegen nationale und europäische Regelungen über PreisangabenFacturation électronique : les sanctions évoluentUrgent Field Safety Notice for MiniMed Paradigm, MiniMed 600 series, MiniMed 700 by Medtronic MinimedFacturation électronique : les sanctions évoluentDiscours de Marie-Anne Barbat-Layani, présidente de l'AMF - Conférence : Afore Consulting, 10th Annual Fintech & Regulation Conference MiCA - "One Year In – Are we seeing the…"ICO wins Court of Appeal case in DSG Retail rulingBasel Committee publishes analysis of synthetic risk transfersCommission supports the EU's eastern regions bordering Russia, Belarus and UkraineESMA43-857238790-1629 - 19/02/2026 - Public notice on supervisory measures and fines imposed on REGIS-TRL'AMF a requis la suspension du titre RAPID NUTRITION et appelle les investisseurs à la vigilanceThe AMF has required the suspension of RAPID NUTRITION shares and calls on investors to be vigilantPosition limits on the salmon derivative contract listed on Euronext Paris Matif - DOC-2026-01EL(26)A/08 - Class 3 Medicines Recall: Norgine Limited, MOVICOL Ease Citrus Powder - 17.02.2026Bulletin d'actualité CERTFR-2026-ACT-007 (16 février 2026)Belgravia waste crook forced to pay £1.4m compensationUrgent Field Safety Notice for IMMULITE 2000 EPO, IMMULITE EPO Control Module by Siemens Healthcare Diagnostics Products Ltd.Multiples vulnérabilités dans Tenable Security CenterAttentes de l’ACPR en vue de l’agrément en qualité d’établissement de paiement des prestataires offrant des services relevant concomitamment de la catégorie des services de paiement et des services sur crypto-actifsTempête et inondations : première réunion de la commission catastrophes naturelles le 24 février[Vidéo] Présentation du bilan de la douane 2025
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    7 min
  • [European Union] Regulatory Insights on Energy, AI, Cybersecurity & Crypto

    [European Union] Regulatory Insights on Energy, AI, Cybersecurity & Crypto
    Feb 17 2026

    Welcome to Carver's European Union Regulatory Updates, featuring the latest in financial regulation, cybersecurity, AI, and digital assets.

    We begin with ESMA's confirmation of new position limits proposed by Germany’s BaFin affecting the European Energy Exchange’s German Power Base contracts, ensuring market integrity across spot and future months.

    In France, the Autorité des marchés financiers (AMF) has officially withdrawn APICAP’s portfolio management license following the transfer or cessation of its alternative investment funds.

    Cybersecurity remains a critical area with multiple severe vulnerabilities disclosed in PostgreSQL databases, IBM, Siemens, and Axis Communications products. Some flaws remain unpatched, emphasizing the urgent need for vigilance and timely updates.

    The French National Institute for AI Evaluation and Security (INESIA) has launched its 2026-2027 roadmap focusing on AI regulation, systemic risk, performance evaluation, and shared tools to promote safer AI deployment.

    Finally, updated guidance on crypto-assets highlights the risks, responsibilities of service providers, and advice on identifying and avoiding scams.

    For more information, visit the Carver Agents website.

    Articles mentioned:

    1. L'AMF announces withdrawal of APICAP portfolio management license
    2. Japanese Minister attends trade minister meeting on critical minerals
    3. ESMA Opinion on position limits for EEX German Power Base contract
    4. François Villeroy de Galhau: New Year wishes to the Paris financial centre
    5. Multiple vulnerabilities in PostgreSQL
    6. Multiple vulnerabilities in IBM products
    7. Multiple vulnerabilities in PostgreSQL (duplicate)
    8. Multiple vulnerabilities in Siemens products
    9. Multiple vulnerabilities in Siemens products (duplicate)
    10. IMF Executive Board concludes 2025 Article IV Consultation with Germany
    11. Germany vows to deepen strategic ties with Central Asian nations
    12. Multiple vulnerabilities in Axis Communications products
    13. Multiple vulnerabilities in Axis Communications products (duplicate)
    14. INESIA roadmap for AI evaluation and security
    15. Updated guidance on investing in crypto-assets
    16. German Minister at Munich Security Conference on energy and resilience
    17. Andrew Bailey: The world today
    18. January 2026 Cyber Weather Report
    19. EMA approval details for Kyinsu (insulin icodec/semaglutide)
    20. AP warns of major security risks with AI agents like OpenClaw
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    4 min
  • [European Union] Key Updates on AI, Cybersecurity & Finance

    [European Union] Key Updates on AI, Cybersecurity & Finance
    Feb 8 2026
    Welcome to this edition of Carver's European Union Regulatory Updates.This podcast highlights critical institutional developments across the EU's financial regulatory landscape. Key topics include:The joint publication by the European Banking Authority, European Securities and Markets Authority, and European Insurance and Occupational Pensions Authority of informational sheets to protect consumers against AI-enabled online financial fraud.Recent disclosures of cybersecurity vulnerabilities impacting Red Hat Linux kernel and IBM products, emphasizing risks to data confidentiality and system integrity.A comprehensive study by the Autorité des Marchés Financiers revealing widespread use of AI, especially generative AI, by French financial market participants, focusing on internal productivity gains and evolving governance frameworks.Preparations required for the Digital Operational Resilience Act (DORA) reporting, mandating annual submission of ICT service provider contracts by EU financial institutions.Insights into tightening credit conditions indicated by recent banking surveys.The episode also references a range of regulatory news, industry studies, and government actions relevant to professionals tracking EU financial and IT regulatory developments.For more information, visit the Carver Agents website.Articles mentioned:Januar-Ergebnisse der Umfrage zum Kreditgeschäft (Bank Lending Survey) in Deutschland Kreditrichtlinien in allen Kreditsegmenten gestrafftFCA stops Advantage Wealth Management Ltd from carrying out regulated activities and imposes assets restrictionSemaglutide (Wegovy, Ozempic and Rybelsus): risk of NAIONDaily newsFrenemies at the gates − speech by Rebecca JacksonA study by the AMF finds widespread levels of adoption in artificial intelligence by French financial market participants02.02.2026 - Etude sur l'usage de l'intelligence artificielle par les acteurs des marchés financiersA study by the AMF finds widespread levels of adoption in artificial intelligence by French financial market participants (RSS)DORA: Reporting DORA registers of information in March 2026Partnerangebot: reuschlaw - Digital Business Conference 2026Survey on the Access to Finance of Enterprises in the euro area - Fourth quarter of 2025Projecting the Interests of a Dynamic Debt Portfolio: a Financial ModelLe autorità di vigilanza UE pubblicano informazioni per aiutare i consumatori a proteggersi dalle truffe finanziare online nell'era dell'IAEBA, ESMA ed EIOPA pubblicano due schede per proteggere i consumatori da frodi online e truffe legate all'IACommission marks five years of Europe's Beating Cancer Plan with strengthened actions to fight cancerMultiples vulnérabilités dans le noyau Linux de Red Hat (06 février 2026)Multiples vulnérabilités dans les produits IBMThe AMF reminds Digital Asset Service Providers that the transitional period allowing them to continue providing crypto-asset services in France without MiCA authorisation ends on 1 July 2026Government leads global fight against deepfake threatsStatement on the commencement of the Data (Use and Access) Act (DUAA)
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    4 min
  • Key EU and UK Regulatory Updates: Securities, Financial Reporting, Cryptoasset Rules & Enforcement Alerts

    Key EU and UK Regulatory Updates: Securities, Financial Reporting, Cryptoasset Rules & Enforcement Alerts
    Jan 31 2026
    Welcome to Carver’s latest regulatory news update.We begin with the European Union’s new regime governing offers of securities, including transferable and non-transferable debt instruments like mini-bonds and loan notes. The updated framework enhances regulatory oversight to protect consumers from unauthorized offers.Next, the Federal Office of Justice has imposed a disciplinary fine on BayWa Aktiengesellschaft for late electronic submission of its 2024 consolidated accounts, highlighting strict enforcement of Germany’s Commercial Code reporting requirements.The 2025 accounts closing introduces IFRS 18 with new presentation and disclosure mandates, alongside amendments to IFRS 9 and IFRS 7 and mandatory application of ANC regulations—strengthening financial statement transparency.Across the Channel, the UK’s Financial Conduct Authority (FCA) is consulting on proposed rules for cryptoasset firms, covering Consumer Duty, conduct standards, redress, safeguarding, training, senior management accountability, regulatory reporting, and credit use policies.The FCA has also issued warnings against several unauthorized operators including Onyx Capital Pro, Wealthexa, Mega Income Options Trading, JustMarketExpert, and PhyxTrade, urging consumers to avoid these high-risk entities.In enforcement news, the U.S. Securities and Exchange Commission continues its vigilance with recent litigation releases.Stay informed and compliant with these critical updates shaping the European and UK financial regulatory landscape.For more information, visit the Carver Agents website.Articles mentioned:Publication of financial reports: Federal Office of Justice imposes disciplinary fine on BayWa AktiengesellschaftNavigating credit dynamics: does it matter for firm-level investment? Evidence from AnaCreditNew regime for securities and what consumers should look out forClosing of the 2025 accounts and examination of the financial statements - DOC-2025-08FCA seeks feedback on further rules for cryptoasset firmsLitigation Release: Joel B. SofiaAllgemeines Meldeportal StatistikGeneral statistics reporting portalTeilnahmebedingungen | Gewinnspiel „Zentralbank.IT.Challenge“Nominations - Emmanuelle Assouan est nommée secrétaire générale de l’ACPR et Xavier Debrun est nommé chef-économiste de la Banque de FranceHäufig gestellte Fragen und Merkblätter„Wir erleben jede Minute mehr als 5.000 Cyberangriffe“ | Interview mit dem TagesspiegelSeminar - The Impact of Borrower-Based Macroprudential Tools: A Mesoeconometric Approach“We see more than 5,000 cyberattacks every minute” | Interview with TagesspiegelLanceur d'alerte : notification de potentielles infractions à la réglementationOnyx Capital Pro / onyxcapitalpro.com (clone of FCA firms)Wealthexa (new)Mega Income Options Trading / megaincomeoptionstrading.com (new)JustMarketExpert (new)PhyxTrade (new)
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    4 min